154
Participants
Start Date
March 27, 2017
Primary Completion Date
August 18, 2017
Study Completion Date
August 18, 2017
Dolutegravir
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
Lamivudine
"Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.\<br\>3TC will be gray, diamond shaped tablet, engraved GX EJ7 on one side and plain on the other side."
Dolutegravir + Lamivudine FDC Formulation 1
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. \<br\>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
Dolutegravir + Lamivudine FDC Formulation 2
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. \<br\>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
GSK Investigational Site, Overland Park
Lead Sponsor
Collaborators (1)
GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY